4; Cal. Code Regs. tit. 4, ยงยง15718-25. 21 U.S.C. ยง 343(q); 21 C.F.R. 101.9(c). 21 U.S.C. ยง343(a). 21 C.F.R. 101.13(i).
NotesSee Federal Food, Drug, and Cosmetic Act (21 U.S.C. ยง 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. ยง 1451, et seq.)See Federal Meat Inspection Act (FMIA; 21 U.S.C. ยง 601 et. seq); Poultry Products Inspection Act (PPIA; 21 U.S.C. ยง 451,et seq.)21 U.S.C. ยงยง 601(n)(1) and 453(h)(1); 21 U.S.C. ยง 343(a).21 U.S.C. ยงยง 601(n)(2) and 453(h)(2); 21 U.S.C. ยง 343(b).
he Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. ยง 501.212(1).The Supremacy Clause of the Constitution provides that the laws of the United States โshall be the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.โ U.S. Const. art. VI cl. 2. The Supremacy Clause thus empowers Congress to preempt state laws. Arizona v. United States, 132 S.Ct. 2492, 2500 (2012). Among others, one way in which Congress may preempt state laws is through express preemption. See Shuford v. Fidelity Nat. Property & Cas. Ins. Co., 508 F.3d 1337, 1344 (11th Cir. 2007). Express preemption occurs โwhen Congress has manifested its intent to preempt state law explicitly in the language of the statute.โ Id.The FDCA generally prohibits the โadulteration or misbranding of any food . . . in interstate commerce.โ 21 U.S.C. ยง 331(b). The FDCA considers a food product misbranded if its labeling is โfalse or misleading in any particular manner.โ 21 U.S.C. ยง 343(a). Congress amended the FDCA in 1990 to โcreate uniform national standards regarding the labeling of food.โ Bruton v. Gerber Products Co., 961 F. Supp. 2d 1062, 1079 (N.D. Cal. 2013). As part of those amendments, Congress explicitly preempted any state labeling requirements that are not identical to federal labeling requirements. Henry, 2016 WL 1589900 at *6; 21 U.S.C. ยง 341-1(a) (โno State or political subdivision of a State may directly or indirectly establish . . . any requirement for the labeling of food of the type required in [the enumerated sections of the FDCA, including ยง 343(i)(2)] that is not identical to the requirement of such sectionโ). Interpreting this preemption clause, courts have consistently found that the FDCA preempts state statute- and common-law-based claims to the extent that they would impose liability for conduct expressly permitted by the FDCA. E.g., Henry, 2016 WL 1589900 at *7 (state-law unfair trade practices claim preempted); Turk v. Gen. Mills, Inc., 662
Labeling Issues The Order does not alter PHO or trans-fat labeling. Two sections of the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. ยงยง 343(q) and (r), directly apply to trans-fat labeling. Section 343(q) enumerates the requirements for the labeling of nutrition information that typically appears in the Nutrition Facts panel. 21 U.S.C. ยง 343(q).
org/responsibility/advertising-marketing-code/lxii Id.lxiii Id.lxiv 21 C.F.R. ยง 101.9; 21 U.S.C. ยง 343(q).lxv 21 C.F.R. ยง 101.36 ; 21 U.S.C. ยง 343(s).
eged a blended version of the product (like the defendantโs product) cannot be labeled โglucosamine sulfate.โThe plaintiffs were wrong, and the district court and the Ninth Circuit both ruled that federal regulation of dietary supplements preempted their state-law claims. How did the courts get there? The starting point is the federal Food Drug & Cosmetics Act, which expressly preempts any state-law requirement for the labeling of food that is not identical to federal requirements. Id. at 1016. A private plaintiff therefore can bring state-law claims only if the state law imposes requirements that are identical to those contained in the FDCA. Id.That was the plaintiffsโ hook in Hollins. They argued that they were seeking to enforce state-law requirements that were identical to federal requirementsโnamely, that a food is misbranded (1) if it is offered for sale under the name of another food or (2) if its label does not bear the FDA-required nutritional information. Id. at 1014 (citing 21 U.S.C. ยงยง 343(b), 343(q)). We understand those rules. Rockfish should not be held out as red snapper, and maple-flavored corn syrup should not be called maple syrup.The problem with the plaintiffsโ glucosamine claims was that FDA regulations clearly allowed the defendant to label its product โglucosamine sulfate.โ The FDA has promulgated regulations governing the labeling for dietary supplements; and for many ingredients, the FDA has established specific reference values. However, where the FDA has not established reference values, such dietary ingredients โshall be declared by their common or usual name.โ Id. at 1014-15.This next part is really important. An ingredientโs โcommon or usual nameโ is determined by specified testing protocols: โOfficial Methods of Analysisโ of the AOAC International or, if no AOAC method is available, โby other reliable and appropriate analytical procedures.โ Id. at 1015. Finally, alternate testing methods must be validatedโoften known as โcompendial test methods.โ Id.Why
Manufacturers can satisfy the actโs labeling requirements in one of two ways:1) including a statement โprinted immediately after or adjacent to the list of ingredientsโ that includes the word โcontainsโ followed by โthe common or usual name of the major food allergen.โ [21 U.S.C. ยง 343(w)(1)(A)].2) listing the major food allergen as an ingredient which, with certain exceptions, must be โfollowed in parentheses by the name of the food source from which the major food allergen is derived.โ
References1 Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry (November 2020) available at https://www.fda.gov/media/143521/download; See also, Voluntary Disclosure of Sesame as Allergen: Draft Guidance for Industry (10 November 2020) (to be published in the Federal Register 12 November 2020) available at https://public-inspection.federalregister.gov/2020-24727.pdf.2 21 U.S.C. ยง 321(qq)(1).3 21 U.S.C. ยง 343(i); 21 CFR 101.4.4 Citizen Petition, Requests that the FDA require sesame based ingredients to be listed by name (sesame) in the ingredient lists of all foods, Docket No. FDA-2014-P-2035, available at https://beta.regulations.gov/docket/FDA-2014-P-2035.5 83 Fed. Reg. 54594 (30 October 2018).6 21 U.S.C. ยง 343 note.
The FDCA only requires that foods imitating other foods bear a label with the word โimitationโ and โimmediately thereafter, the name of the food imitated.โ 21 U.S.C. ยง 343(c); 21 C.F.R. ยง 101.3(e).
Instead, she contends that it does not matter, because โthe law was settled long ago by the relevant statutes and regulations.โ The FDAโs 2016 Final Guidance simply clarified FDAโs position that the use of ECJ instead of sugar is false and misleading under 21 U.S.C. ยง343(a)(1) and its accompanying regulations.[1] Therefore, Plaintiff argues that Jelly Bellyโs use of the term ECJ instead of sugar on Sports Beansโ label violates these regulations and ยง343(a)(1).